Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Endocrine Colon in Humans (Colon)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159181
Recruitment Status : Active, not recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborator:
Hvidovre University Hospital
Information provided by (Responsible Party):
Simon Veedfald, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE July 9, 2018
First Posted Date  ICMJE November 12, 2019
Last Update Posted Date November 12, 2019
Actual Study Start Date  ICMJE July 16, 2018
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
GLP-1 [ Time Frame: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min ]
Plasma concentrations of glucagon-like peptide-1 (GLP-1)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
  • PYY [ Time Frame: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min ]
    Plasma concentrations of peptide YY (PYY)
  • Hydrogen breath test [ Time Frame: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min ]
    Concentrations of hydrogen in exhaled air
  • Ghrelin [ Time Frame: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min ]
    Plasma concentrations of ghrelin
  • Motilin [ Time Frame: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min ]
    Plasma concentrations of motilin
  • Neurotensin [ Time Frame: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min ]
    Plasma concentrations of Neurotensin
  • Glucagon [ Time Frame: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min ]
    Plasma concentrations of glucagon
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Endocrine Colon in Humans
Official Title  ICMJE Investigations of the Endocrine Colon in Healthy Individuals
Brief Summary This study will examine the role of the colon as an endocrine organ with a focus on the secretion of gastrointestinal peptides.
Detailed Description

This study will examine the role of the colon as an endocrine organ with a focus on the secretion of gastrointestinal peptides.

We aim to determine the contribution of the colon to the fasting and postprandial release of gut peptides such as glucagon-like peptide-1 (GLP-1) and peptide YY (PYY). Young healthy men will be examined on three occasions at a clinical research Facility after an overnight fast. On one occasion the colon will also be emptied using a cathartic (picoprep). On two occasions an oral solution of lactulose will be administered to stimulate fermentation by colonic bacteria.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Healthy men studied on three occasions. Study A and B will be conducted in random order. Day C wil always be conducted as the last study day.
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Other: Lactulose
    Oral solution lactulose (20g lactulose/200mL water).
  • Other: Picoprep
    Cathartic to accomplish an evacuation of the colonic content.
  • Other: Placebo (water)
    oral administration of Water (200mL).
Study Arms  ICMJE
  • Experimental: Day A
    After an overnight fast participants will receive an oral solution of lactulose (20g lactulose/200mL water).
    Intervention: Other: Lactulose
  • Experimental: Day B
    After an overnight fast participants will drink 200mL of water
    Intervention: Other: Placebo (water)
  • Experimental: Day C
    After an overnight fast and an evacuation of the colonic content, participants will receive an oral solution of lactulose (20g lactulose/200mL water).
    Interventions:
    • Other: Lactulose
    • Other: Picoprep
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 7, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2020
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy young men (self-reported)
  • BMI between 18,5-24,9 kg/m^2

Exclusion Criteria:

  • Diabetes mellitus (elevated fasting plasma glucose or HbA1c)
  • Family history of diabetes mellitus
  • Intestinal disease (e.g. inflammatory bowel disease, malabsorption)
  • Family history of intestinal diseases
  • Previous gastrointestinal surgery
  • BMI >25 kg/m^2
  • Tobacco use
  • Alcohol consumption > 14 standard drinks/week
  • Drug use
  • Kidney, Heart- or Liver disease
  • Treatment with prescription drugs that can not be held for 12h
  • Constipation
  • Accelerated or delayed gastric emptying
  • Absence of daily bowel movements
  • Vegetarian lifestyle
  • > than 3kgs weightloss or weight gain within 3 months
  • Haemoglobin concentration < 8,0mmol/L
  • Bleeding diathesis
  • Latex or bandaid allergies
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04159181
Other Study ID Numbers  ICMJE CBC-COLON-18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Simon Veedfald, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE Hvidovre University Hospital
Investigators  ICMJE
Study Director: Jens J Holst, MD, Dr.med. University of Copenhagen
PRS Account University of Copenhagen
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP